NL-OMON40807
Completed
N/A
HeartMate PHP CE Mark Clinical Investigation - HeartMate PHP
Thoratec Corporation0 sites10 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Coronary sclerosis
- Sponsor
- Thoratec Corporation
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- At least 18 years of age.
- •\- Patient presents with a non\-emergent need for complex PCI with:
- •1\) an ejection fraction of \<\=35% requiring hemodynamic support during the procedure,
- •2\) the heart team has determined that the patient is not an optimal surgical candidate, OR the patient elects not to undergo surgery
- •\- Written, signed, and dated informed consent
Exclusion Criteria
- •\- Emergent PCI
- •\- ST elevation myocardial infarction within 7 days of procedure
- •\- Cardiac arrest within 7 days of procedure requiring CPR or defibrillation
- •\- Hemodynamic support with the HeartMate PHP post\-PCI is anticipated
- •\- Cardiogenic shock (SBP \<90 mmHg for \>1 hour with either cool clammy skin OR oliguria OR altered sensorium OR cardiac index \<2\.2 L/min/m2\)
- •\- Mural thrombus in the left ventricle
- •\- History of aortic valve replacement
- •\- Documented presence of aortic stenosis (orifice area of 1\.5 cm2 or less)
- •\- Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher )
- •\- Severe peripheral vascular disease
Outcomes
Primary Outcomes
Not specified
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